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PharmaCompass offers a list of Hydrocortisone Butyrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Hydrocortisone Butyrate manufacturer or Hydrocortisone Butyrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrocortisone Butyrate manufacturer or Hydrocortisone Butyrate supplier.
PharmaCompass also assists you with knowing the Hydrocortisone Butyrate API Price utilized in the formulation of products. Hydrocortisone Butyrate API Price is not always fixed or binding as the Hydrocortisone Butyrate Price is obtained through a variety of data sources. The Hydrocortisone Butyrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hydrocortisone 17-Butyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrocortisone 17-Butyrate, including repackagers and relabelers. The FDA regulates Hydrocortisone 17-Butyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrocortisone 17-Butyrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Hydrocortisone 17-Butyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrocortisone 17-Butyrate supplier is an individual or a company that provides Hydrocortisone 17-Butyrate active pharmaceutical ingredient (API) or Hydrocortisone 17-Butyrate finished formulations upon request. The Hydrocortisone 17-Butyrate suppliers may include Hydrocortisone 17-Butyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrocortisone 17-Butyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydrocortisone 17-Butyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydrocortisone 17-Butyrate active pharmaceutical ingredient (API) in detail. Different forms of Hydrocortisone 17-Butyrate DMFs exist exist since differing nations have different regulations, such as Hydrocortisone 17-Butyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydrocortisone 17-Butyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydrocortisone 17-Butyrate USDMF includes data on Hydrocortisone 17-Butyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydrocortisone 17-Butyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydrocortisone 17-Butyrate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Hydrocortisone 17-Butyrate Drug Master File in Japan (Hydrocortisone 17-Butyrate JDMF) empowers Hydrocortisone 17-Butyrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Hydrocortisone 17-Butyrate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydrocortisone 17-Butyrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Hydrocortisone 17-Butyrate suppliers with JDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Hydrocortisone 17-Butyrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydrocortisone 17-Butyrate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Hydrocortisone 17-Butyrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Hydrocortisone 17-Butyrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydrocortisone 17-Butyrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydrocortisone 17-Butyrate suppliers with NDC on PharmaCompass.
Hydrocortisone 17-Butyrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Hydrocortisone 17-Butyrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Hydrocortisone 17-Butyrate GMP manufacturer or Hydrocortisone 17-Butyrate GMP API supplier for your needs.
A Hydrocortisone 17-Butyrate CoA (Certificate of Analysis) is a formal document that attests to Hydrocortisone 17-Butyrate's compliance with Hydrocortisone 17-Butyrate specifications and serves as a tool for batch-level quality control.
Hydrocortisone 17-Butyrate CoA mostly includes findings from lab analyses of a specific batch. For each Hydrocortisone 17-Butyrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Hydrocortisone 17-Butyrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydrocortisone 17-Butyrate EP), Hydrocortisone 17-Butyrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydrocortisone 17-Butyrate USP).
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